Aquestive Therapeutics Announces Successful Completion of Phase 1 Trial for AQST-108 (Sublingual Film Formulation Delivering...
September 30 2019 - 7:00AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty
pharmaceutical company focused on developing and commercializing
differentiated products to solve therapeutic problems, today
announced the successful completion of its Phase 1 dose escalation
proof-of-concept study in healthy subjects for AQST-108.
AQST-108 is a “first of its kind” oral sublingual film formulation
delivering systemic epinephrine that is in development for the
treatment of anaphylaxis using Aquestive’s proprietary PharmFilm®
technologies.
Importantly, the data demonstrated that
AQST-108:
- achieved similar ranges of mean values of maximum concentration
(Cmax) and time to reach maximum concentration (Tmax) to that
reported for injectables EpiPen® and Auvi-Q®
- provided a greater total exposure (AUC0-t; area under the
curve) than that reported for EpiPen and Auvi-Q
- had less interpatient variability when compared to degree of
variation (CV%) data reported for EpiPen and Auvi-Q
- was well tolerated, with no study participants discontinuing
participation due to an adverse event
Based on the results of this proof-of-concept
study, Aquestive is in the process of scheduling a pre-IND meeting
with the U.S. FDA.
“We’re very pleased with the proof-of-concept
data that demonstrated our ability to deliver systemic epinephrine
via our PharmFilm formulation,” said Keith J. Kendall, Chief
Executive Officer of Aquestive. “Anaphylaxis is a serious condition
that impacts a large patient population. The only options
currently available to patients require an injection. We
believe we have the technology that can bring meaningful innovation
and positive change for patients. We plan on meeting with the U.S.
FDA as soon as possible to discuss the further development of
AQST-108 and we are focused on providing the first highly portable,
easy-to-administer and anxiety-free oral sublingual film medication
to treat this serious condition.”
Anaphylaxis is a potentially life-threatening
systemic allergic reaction, with an estimated incidence of 50 to
112 episodes per 100,000 people per year. The frequency of hospital
admissions for anaphylaxis has increased 500-700% in the last 10-15
years.1 The most common causes of reactions that can include
anaphylaxis are medications, foods (such as peanuts), and venom
from insect stings. Epinephrine injection is the current standard
of treatment intended to reverse the potentially severe
manifestation of anaphylaxis, which may include red rash, throat
swelling, respiratory problems, gastrointestinal distress and loss
of consciousness.
About Aquestive
TherapeuticsAquestive Therapeutics is a specialty
pharmaceutical company that applies innovative technology to solve
therapeutic problems and improve medicines for patients. Aquestive
is advancing a late-stage proprietary product pipeline to treat CNS
conditions and provide alternatives to invasively administered
standard of care therapies. The Company also collaborates with
other pharmaceutical companies to bring new molecules to market
using proprietary, best-in-class technologies, like PharmFilm®, and
has proven capabilities for drug development and
commercialization.
Forward-Looking StatementThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “believe,” "anticipate," "plan," "expect,"
"estimate," "intend," "may," "will," or the negative of those
terms, and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements may
include, but are not limited to, statements regarding the
therapeutic benefit and safety profile of AQST-108, the
applicability of interim results to the results of later trials,
the development and commercialization of AQST-108, plans and
objectives for present and future clinical trials for AQST-108 and
results of such trials, plans and objectives for regulatory
approval; statements about our growth and future financial and
operating results and financial position, ability to advance
Libervant and our other product candidates to the market,
regulatory approvals and pathways, clinical trial timing and plans,
short-term and long-term liquidity and cash requirements, cash
funding and cash burn, business strategies, market opportunities,
and other statements that are not historical facts.
These forward-looking statements are based on
our current expectations and beliefs and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
Such risks and uncertainties include, but are not limited to, risks
associated with the Company's development work, including any
delays or changes to the timing, cost and success of our product
development activities and clinical trials; risk of delays in FDA
approval of our drug candidates or failure to receive approval;
risk inherent in commercializing a new product (including
technology risks, financial risks, market risks and implementation
risks and regulatory limitations); risk that a competitor obtains
orphan drug exclusivity and blocks our product for the same
indication for seven years; risk of development of our sales and
marketing capabilities; risk of legal costs associated with and the
outcome of our patent litigation challenging third party at risk
generic sale of our proprietary products; risk of sufficient
capital and cash resources, including access to available debt and
equity financing and revenues from operations, to satisfy all of
our short-term and longer term cash requirements and other cash
needs, at the times and in the amounts needed; risk of failure to
satisfy all financial and other debt covenants and of any default;
risk related to government claims against Indivior for which we
license, manufacture and sell Suboxone and which accounts for the
substantial part of our current operating revenues; risks related
to the outsourcing of certain sales, marketing and other
operational and staff functions to third parties; risk of the rate
and degree of market acceptance of our products and product
candidates; the success of any competing products, including
generics; risk of the size and growth of our product markets; risk
of compliance with all FDA and other governmental and customer
requirements for our manufacturing facilities; risks associated
with intellectual property rights and infringement claims relating
to the Company's products; risk of unexpected patent developments;
the impact of existing and future legislation and regulatory
provisions on product exclusivity; legislation or regulatory action
affecting pharmaceutical product pricing, reimbursement or access;
risk of claims and concerns that may arise regarding the safety or
efficacy of the Company's products and product candidates; risk of
loss of significant customers; risks related to legal proceedings,
including patent infringement, investigative and antitrust
litigation matters; changes in governmental laws and regulations;
risk of product recalls and withdrawals; uncertainties related to
general economic, political, business, industry, regulatory and
market conditions and other unusual items; and other risks and
uncertainties affecting the Company including those described in
the "Risk Factors" section and in other sections included in the
Company's Annual Report on Form 10‑K filed with the SEC on
March 14, 2019 and in our quarterly reports on Form 10-Q. Given
these uncertainties, you should not place undue reliance on these
forward-looking statements, which speak only as of the date made.
All subsequent forward-looking statements attributable to us or any
person acting on our behalf are expressly qualified in their
entirety by this cautionary statement. The Company assumes no
obligation to update forward-looking statements or outlook or
guidance after the date of this press release whether as a result
of new information, future events or otherwise, except as may be
required by applicable law.
PharmFilm® and the Aquestive logo are registered
trademarks of Aquestive Therapeutics, Inc. All other
trademarks are the property of their respective owners.
____________________________1 Epidemiology of
anaphylaxis. Tejedor Alonso MA, Moro Moro M, Mugica Garcia MC, Clin
Exp Allergy. 45(6):1027-39, Jun 2015
Media and Investor inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
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